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RecruitingNCT07921095tDCSUpdated Nov 6, 2026

Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP

An interventional study of Action Observation Therapy and Transcranial Direct Current Stimulation in Diplegic Cerebral Palsy, sponsored by Riphah International University. Recruiting at 1 site in Pakistan. Open to participants aged 5 Years to 15 Years. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by Riphah International University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Jul 2026, registered Nov 2026).
  • Started Jul 2026; still recruiting 4 months later.
Updated Nov 6, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
5 Years to 15 Years
Sex
All
01

Study summary

The goal of this clinical trial is to evaluate the therapeutic effects of combining active transcranial direct current stimulation (tDCS) with Action Observation Therapy (AOT) in pediatric patients diagnosed with spastic Cerebral Palsy. The main questions it aims to answer are:

  1. Does combining tDCS with AOT yield significantly greater improvements in gross motor function (measured by GMFM-88) compared to AOT alone?
  2. Does active tDCS paired with AOT lead to greater reductions in spasticity (MAS) and improvements in walking speed (10MWT) at 6 weeks post-intervention?

Researchers will compare participants receiving active tDCS plus AOT against a control group receiving sham tDCS plus AOT to isolate the synergistic effects of active brain stimulation.

Participants will:

  1. Complete baseline clinical evaluations including gross motor, spasticity, and gait assessments.
  2. Undergo scheduled intervention sessions consisting of tDCS administration combined with video-based Action Observation Therapy.
  3. Attend follow-up assessment sessions at the end of the intervention period and 6 weeks post-intervention.
02

Conditions studied

  • Diplegic Cerebral Palsy

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03

In context

Cerebral Palsy

1,936 studies on the registry are indexed under Cerebral Palsy; 458 are open to participants now.

This study's planned enrollment of 40 is above the median of 34 across 1,431 interventional studies indexed under Cerebral Palsy.

Browse Cerebral Palsy studies →

Lead sponsor

Riphah International University is the lead sponsor of 2,193 studies on the registry; 650 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Participants diagnosed with spastic diplegic cerebral palsy with a Modified Ashworth Scale (MAS) score of 2
  2. Age between 6 to 12 years old
  3. Participants classified as Communication Function Classification System (CFCS) Level II
  4. Participant with CFCS Level II

Exclusion criteria

Exclusion Criteria:

  1. Presence of uncontrolled epilepsy (any seizure within the past 6 months).
  2. Implanted metallic or electronic devices (e.g., pacemaker, cochlear implant, deep brain stimulator).
  3. Severe dystonia, ataxia, or predominant weakness interfering with upper limb or lower limb function.
  4. Severe visual impairment (not correctable with aids) preventing participation in action observation tasks.
  5. Botulinum toxin injections in the affected limb(s) within the past 6 months or planned during study period.
  6. Orthopedic surgery to the affected limb(s) within the past 12 months or planned during study period.
  7. Skin conditions, lesions, or infections at electrode placement sites.
  8. Current use of medications significantly affecting cortical excitability (e.g., high-dose benzodiazepines, anticonvulsants), unless cleared by neurologist.
  9. Participation in another interventional clinical trial within the past 3 months.
  10. Any medical or psychiatric condition that, in the investigator's judgment, makes participation unsafe or interferes with study outcomes.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
40 participants (estimated)

Study arms

  • Active comparator
    Experimental Group

    TDCS+ Action observation Therapy

    Other: Action Observation Therapy · Device: Transcranial Direct Current Stimulation

  • Sham comparator
    Control Group

    Sham TDCs + Action Observation Therapy

    Other: Action Observation Therapy · Device: Sham TDCs

Interventions

  • OtherAction Observation Therapy

    Observation of video recorded

  • DeviceTranscranial Direct Current Stimulation

    Active Anodal tDCS (1-1.5 mA)

  • DeviceSham TDCs

    Sham TDCs

06

What researchers measure

Primary outcomes

  1. Gross Motor Functional Measurement (GMFM-88)

    Assessment of Gross Motor Capacity focusing on standing

    Time frame: Baseline and 6 months (post - intervention)

Secondary outcomes

  1. 10-Meter Walk Test (10MWT)

    Measures walking speed in meters per second over 10 meters

    Time frame: Baseline and 6 weeks (post-intervention)

  2. Modified Ashworth Scale (MAS) - Muscle tone

    Evaluate muscle spasticity in lower limb joints

    Time frame: Baseline and 6 weeks (post-intervention)

07

Study locations

1 of 1 sites recruiting
  • Alam Family Hospital
    Wah, Punjab Province 47000, Pakistan
    Recruiting
08

References and documents

Publications

  • Magdy E, Hanna S, Shoukry KE-S. Effect of Action Observation Training on Gross Motor Functions in Children with Spastic Cerebral Palsy. Egyptian Journal of Hospital Medicine. 2025;97(1):3820-6.
  • Zhong M, Zhang Y, Luo J, Chen T, Zhang J, Peng T Sr, Han M, Le W, Peng T Jr, Xu K. Safety and effectiveness of non-invasive brain stimulation on mobility and balance function in children with cerebral palsy: a systematic review and meta-analysis. J Neuroeng Rehabil. 2025 May 18;22(1):111. doi: 10.1186/s12984-025-01619-7. PubMed 40383797 ↗
  • Lench DH, Christopher P, Gavioli M, Nytes G, Ikonomidou C, Villegas MA, Gillick BT. Long-term outcome safety assessment after teleneuromodulation in children with cerebral palsy. Brain Stimul. 2024 May-Jun;17(3):633-635. doi: 10.1016/j.brs.2024.04.017. Epub 2024 May 11. No abstract available. PubMed 38740181 ↗
  • Stein A, Riddle J, Caulfield KA, Dux PE, Friehs MA, Schroeder PA, Craven MP, Groom MJ, Iyer KK, Barlow KM. Safety, Feasibility, and Tolerability of Ten Days of At-Home, Remotely Supervised tDCS During Gamified Attention Training in Children with Acquired Brain Injury: An Open-Label, Dose-Controlled Pilot Trial. Brain Sci. 2025 May 24;15(6):561. doi: 10.3390/brainsci15060561. PubMed 40563733 ↗
  • Farzamfar P, Heirani A, Amiri E, Sedighi M, da Silva Machado DG. The Effect of Transcranial Direct Current Stimulation on M1 with and without Mirror Visual Feedback on Range of Motion and Hand Grip Strength of the Affected Upper Limb in Children with Spastic Hemiplegic Cerebral Palsy. Iran J Child Neurol. 2024 Fall;18(4):93-106. doi: 10.22037/IJCN.V18I4.45110. Epub 2024 Sep 29. PubMed 39478944 ↗
  • Tang L, Wu Y, Ma J, Lu Y, Wang L, Shan C. Application of tDCS in children with cerebral palsy: A mini review. Front Pediatr. 2022 Sep 20;10:966650. doi: 10.3389/fped.2022.966650. eCollection 2022. PubMed 36204667 ↗
  • Christopher P, Sutter EN, Gavioli M, Lench DH, Nytes G, Mak V, Simpson EA, Ikonomidou C, Villegas MA, Saiote C, Gillick BT. Safety, tolerability and feasibility of remotely-instructed home-based transcranial direct current stimulation in children with cerebral palsy. Brain Stimul. 2023 Sep-Oct;16(5):1325-1327. doi: 10.1016/j.brs.2023.08.024. Epub 2023 Aug 29. No abstract available. PubMed 37652136 ↗
  • He W, Huang Y, He L, Liu L, Zeng P, Qiu H, Wang X, Zhou H, Chen Z, Xu Y, Zhao J, Wang W, Tang H, Xu K. Safety and effects of transcranial direct current stimulation on hand function in preschool children with hemiplegic cerebral palsy: A pilot study. Front Behav Neurosci. 2022 Sep 9;16:925122. doi: 10.3389/fnbeh.2022.925122. eCollection 2022. PubMed 36160682 ↗
  • Beani E, Menici V, Sicola E, Ferrari A, Feys H, Klingels K, Mailleux L, Boyd R, Cioni G, Sgandurra G. Effectiveness of the home-based training program Tele-UPCAT (Tele-monitored UPper Limb Children Action Observation Training) in unilateral cerebral palsy: a randomized controlled trial. Eur J Phys Rehabil Med. 2023 Oct;59(5):554-563. doi: 10.23736/S1973-9087.23.07945-5. Epub 2023 Jul 18. PubMed 37462399 ↗
  • Jeong YA, Lee BH. Effect of Action Observation Training on Spasticity, Gross Motor Function, and Balance in Children with Diplegia Cerebral Palsy. Children (Basel). 2020 Jun 18;7(6):64. doi: 10.3390/children7060064. PubMed 32570855 ↗
  • Errante A, Beccani L, Verzelloni J, Maggi I, Filippi M, Bressi B, Ziccarelli S, Bozzetti F, Costi S, Ferrari A, Fogassi L. Effectiveness of action observation treatment based on pathological model in hemiplegic children: a randomized-controlled trial. Eur J Phys Rehabil Med. 2024 Aug;60(4):643-655. doi: 10.23736/S1973-9087.24.08413-2. Epub 2024 May 30. PubMed 38814197 ↗
  • Simon-Martinez C, Mailleux L, Jaspers E, Ortibus E, Desloovere K, Klingels K, Feys H. Effects of combining constraint-induced movement therapy and action-observation training on upper limb kinematics in children with unilateral cerebral palsy: a randomized controlled trial. Sci Rep. 2020 Jun 26;10(1):10421. doi: 10.1038/s41598-020-67427-2. PubMed 32591590 ↗
  • Beani E, Matteucci E, Sicola E, Martini G, Di Lieto MC, Bombonato C, Menici V, Cotardo A, Rizzo M, Filogna S, Camuncoli F, Biagi L, Cioni G, Fedeli F, Gelmini C, Neviani R, Vecchi O, Perazza S, Faccioli S, Errante A, Piras A, Sicuri E, Bozzetti F, Boyd RN, Ferrari A, Fogassi L, Sgandurra G. ACT-ON-DIP: Study Protocol of a Randomized Controlled Trial of a Home-Based ACTion Observation Tele-RehabilitatioN for Upper Limb in Children with DIPlegic Cerebral Palsy. Children (Basel). 2025 Sep 14;12(9):1229. doi: 10.3390/children12091229. PubMed 41007094 ↗

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07921095
Lead sponsor
Riphah International University
Responsible party
Sponsor
First posted
Nov 6, 2026
Start date
Jul 1, 2026
Primary completion
Nov 1, 2026 (estimated)
Completion
Jan 1, 2027 (estimated)
Last update
Nov 6, 2026

Study contacts

Dr. Ayesha Bashir, MS-NMPT
Contact
ayesha.bashir@riphah.edu.pk/
+923335256920
Ayesha Bashir
Contact
Ayesha Bashir
principal investigator · Riphah International University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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